Claims for Patent: 10,300,229

Summary for Patent: 10,300,229

Title:	Nasal delivery devices
Abstract:	A nasal delivery device for and method of delivering substance to a nasal airway of a subject, the delivery device comprising: a nosepiece (117) for fitting to a nasal cavity of a subject; a mouthpiece (119) into which the subject in use exhales; a delivery unit, which comprises an actuation part which is manually displaceable to actuate the delivery unit to deliver substance from the nosepiece; and a valve assembly (127) which is fluidly connected to the nosepiece and the mouthpiece, wherein the valve assembly comprises a body element (128) and a valve element (131) which is movably disposed to the body element between closed and open configurations by manual displacement of the actuation part of the delivery unit to provide for an air flow through the nosepiece simultaneously with delivery of substance.
Inventor(s):	Djupesland; Per Gisle (Oslo, NO), Leclerc; Michael (Cranston, RI), Mahmoud; Ramy A. (Skillman, NJ), Siwinski; Shane (Providence, RI), Gordon; Joseph (Mansfield, MA), Fisk; Justin (Providence, RI)
Assignee:	OptiNose AS (Oslo, NO)
Application Number:	14/380,827
Patent Claims:	1. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising; a nosepiece for fitting to a nasal cavity of the subject; a mouthpiece into which the subject in use exhales; a mechanical delivery puma, which comprises an actuator which is manually displaceable to actuate the delivery pump to deliver substance from the nosepiece; and a valve assembly which is fluidly connected to the nosepiece and the mouthpiece, wherein the valve assembly comprises a body element and a valve element movable relative to the body element between closed and open configurations by manual displacement of the actuator of the delivery pump to provide for an air flow through the nosepiece simultaneously with delivery of substance; wherein the body element includes a pivot, and the valve element comprises an arm having a first end pivotally connected to the body element and configured to pivot between the closed and open configurations. 2. The delivery device of claim 1, wherein the arm is at least in part resilient. 3. The delivery device of claim 1, wherein the arm has a second end and the body element includes a sliding surface, against which the second end of the arm is slideable. 4. The delivery device of claim 1, wherein the arm comprises a first arm section, which is configured such that, when the valve element is in the closed configuration, the first arm section is engageable by displacement of the actuator of the delivery pump. 5. The delivery device of claim 4, wherein the arm is biased inwardly relative to a longitudinal axis of the delivery device. 6. The delivery device of claim 4, wherein the arm comprises a second arm section which engages the sliding surface of the body element. 7. The delivery device of claim 6, wherein the second arm section is a resilient section which acts to bias the valve element to the closed configuration. 8. The delivery device of claim 6, wherein the first and second arm sections enclose an obtuse angle. 9. The delivery device of claim 1, wherein the arm is inclined inwardly relative to a longitudinal axis of the delivery device when the valve element is in the closed configuration. 10. The delivery device of claim 1, wherein the body element includes a valve seat which defines a valve opening, and the valve element comprises a seal which acts to close the valve opening when the valve element is in the closed position. 11. The delivery device of claim 10, wherein the valve element comprises a support which supports a central region of the seal, such as to allow a peripheral region of the seal to engage the valve seat and the central region to be deflected relative to the peripheral region, thereby allowing for sudden release of the seal. 12. The delivery device of claim 10, wherein the valve element comprises a support which extends substantially across a width of the valve opening. 13. The delivery device of claim 10, wherein the seal is separate to and not supported by the arm, and displaced by movement of the arm, optionally the seal comprises a resilient element, and the arm comprises an engagement element which engages the seal with the movement of the arm, optionally the seal comprises a resilient flap. 14. The delivery device of claim 10, wherein the seal comprises a resilient element. 15. The delivery device of claim 1, wherein the valve assembly, on opening of the valve element, provides for a burst of air flow, having a first, initial burst phase followed by a second, extended burst phase, wherein the peak flow rate in the first burst phase has a higher flow rate than the average flow rate in the second burst phase, and the second burst phase is of greater duration than the first burst phase, and wherein the peak flow rate in the first burst phase is at least 10% greater than that of the average flow rate of the second burst phase as compared across a period ten times longer than the period in which substance is delivered. 16. The delivery device of claim 15, wherein the peak flow rate in the first burst phase is at least 15% greater than that of the average flow rate of the second burst phase. 17. The delivery device of claim 15, wherein the peak flow rate in the first burst phase is at least 20% greater than that of the average flow rate of the second burst phase. 18. The delivery device of claim 1, further comprising: a housing which includes an aperture through which the actuator of the delivery pump extends. 19. The delivery device of claim 18, wherein the housing further comprises a seal which slideably receives the actuator to prevent air flow from the aperture in the housing. 20. The delivery device of claim 1, wherein the valve assembly provides for a pre-actuation efficiency of less than 5 L/min when the subject is developing an exhalation pressure of 3 kPa. 21. The delivery device of claim 20, wherein the valve assembly provides for a pre-actuation efficiency of less than 1 L/min when the subject is developing an exhalation pressure of 3 kPa. 22. The delivery device of claim 20, wherein the valve assembly provides for a pre-actuation efficiency of 0 L/min when the subject is developing an exhalation pressure of 3 kPa. 23. The delivery device of claim 20, wherein the valve assembly provides for a pre-actuation efficiency of less than 5 L/min when the subject is developing an exhalation pressure of 10 kPa. 24. The delivery device of claim 21, wherein the valve assembly provides for a pre-actuation efficiency of less than 1 L/min when the subject is developing an exhalation pressure of 10 kPa. 25. The delivery device of claim 24, wherein the delivery device is configured to provide at least 90% of the air as delivered into the mouthpiece to the nosepiece when delivered at a flow rate of 50 L/min and an exhalation pressure of 3 kPa. 26. The delivery device of claim 22, wherein the valve assembly provides for a pre-actuation efficiency of 0 L/min when the subject is developing an exhalation pressure of 10 kPa. 27. The delivery device of claim 1, wherein the delivery device is configured to provide at least 80% of the air as delivered into the mouthpiece to the nosepiece when delivered at a flow rate of 50 L/min and an exhalation pressure of 3 kPa. 28. The delivery device of claim 27, wherein the delivery device is configured to provide at least 88% of the air as delivered into the mouthpiece to the nosepiece when delivered at a flow rate of 50 L/min and an exhalation pressure of 3 kPa. 29. The delivery device of claim 1, wherein the delivery pump provides for delivery of substance subsequent to opening of the valve element. 30. The delivery device of claim 29, wherein the delivery pump provides for delivery of substance in a period less than about 250 ms from opening of a sealing member of the valve assembly. 31. The delivery device of claim 30, wherein the delivery a pump provides for delivery of substance in a period less than about 200 ms from opening of the sealing member. 32. The delivery device of claim 30, wherein the delivery pump provides for delivery of substance in a period less than about 150 ms from opening of the sealing member. 33. The delivery device of claim 30, wherein the delivery pump provides for delivery of substance in a period less than about 100 ms from opening of the sealing member. 34. The delivery device of claim 29, wherein the delivery pump provides for delivery of substance commencing less than about 150 ms subsequent to opening of the valve element. 35. The delivery device of claim 34, wherein the delivery pump provides for delivery of substance commencing less than about 100 ms subsequent to opening of the valve element. 36. The delivery device of claim 34, wherein the delivery pump provides for delivery of substance commencing less than about 50 ms subsequent to opening of the valve element. 37. The delivery device of claim 34, wherein the delivery pump provides for delivery of substance commencing less than about 25 ms subsequent to opening of the valve element. 38. The delivery device of claim 34, wherein the delivery pump provides for delivery of substance commencing less than about 15 ms subsequent to opening of the valve element. 39. The delivery device of claim 1, wherein the delivery pump comprises an outlet from which substance is delivered through the nosepiece. 40. The delivery device of claim 39, wherein the delivery pump comprises a substance-containing chamber. 41. The delivery device of claim 39, wherein the outlet is a spray nozzle. 42. A method of delivering substance to a nasal airway of a subject, comprising the steps of: fitting a nosepiece to a nasal cavity of the subject; the subject exhaling into a mouthpiece; providing a delivery device which comprises: a mechanical delivery pump, which comprises an actuator which is manually displaceable to actuate the delivery pump to deliver substance from the nosepiece; and a valve assembly which is fluidly connected to the nosepiece and the mouthpiece, wherein the valve assembly comprises a body element and a valve element movable relative to the body element between closed and open configurations by manual displacement of the actuator of the delivery pump, wherein the body element includes a pivot, and the valve element comprises an arm having a first end pivotal connected to the body element and configured to pivot between the closed and open configurations; and manually displacing the actuator of the delivery pump to move the valve element of the valve assembly relative to the body element of the valve assembly between closed and open configurations and provide an air flow through the nosepiece simultaneously with delivery of substance. 43. A nasal delivery device for delivering substance to a nasal airway of a subject, comprising: a nosepiece for fitting to a nasal cavity of the subject; a mouthpiece into which the subject in use exhales; a mechanical delivery pump, which comprises an actuator which is manually displaceable to actuate the delivery pump to deliver substance from the nosepiece; and a valve assembly which is fluidly connected to the nosepiece and the mouthpiece, wherein the valve assembly comprises a body element and a valve element movable relative to the body element between closed and open configurations by manual displacement of the actuator of the delivery pump to provide for an air flow through the nosepiece simultaneously with delivery of substance; wherein the body element includes a pivot, and the valve element comprises an arm having a first end pivotally connected to the body element and configured to pivot between the closed and open configurations; and wherein the valve assembly, on opening of the valve element, provides for a burst of air flow, having a first, initial burst phase followed by a second, extended burst phase, wherein the peak flow rate in the first burst phase has a higher flow rate than the average flow rate in the second burst phase, and the second burst phase is of greater duration than the first burst phase.